ANZCTR search results

Severe alcohol-associated hepatitis (SAH) is a huge unmet medical need, associated with high mortality. Corticosteroids have not been associated with improved long-term survival benefit and there has been no improvement in survival in SAH with medical management during the last 60 years. SAH is associated with impaired growth of new cells in your liver (known as hepatocyte proliferation). Elevated Wnt signaling and increased hepatocyte proliferation have been linked to greater survival, suggesting that therapies that can enhance hepatocyte proliferation can benefit patients. R-spondins (RSPOs) are known enhancers of Wnt signaling. SZN-043 is a bispecific fusion protein and hepatocyte-specific RSPO mimetic shown to bring on hepatocyte-targeted Wnt signaling and hepatocyte proliferation in research studies performed in laboratories. SZN-043 was evaluated for safety and how the drug behaves in the human body in a single center, first-in-human study in healthy volunteers and patients with mild cirrhosis of the liver. This second study will evaluate the same things in patients who have severe AH.

This study aims to evaluate the clinical safety and performance of the TRAX Cruciate Retaining (CR) Total Knee System (TKS) used in primary Total Knee Arthroplasty (TKA) The study is prospective, multi-centre, non-randomised, comparative and single arm. The clinical safety will be evaluated through the analysis of adverse events and serious adverse events and thorough the 2-year survivorship of the system. Performance wil be evaluated through functional measurements and questionnaires. The clinical and safety performance of the TRAX CR TKS will be compared to the ones of modern cemented CR TKS used in primary TKA in Australia.

The determination of a specific diagnosis in patients with polyuria syndromes is a frequent problem in clinical practice. Determining the correct diagnosis is crucial to optimising the management of these conditions as treatment approaches differ, and both inadequate and incorrect treatment can cause severe complications. However, differentiating these conditions, particularly arginine vasopressin deficiency (AVP-D) and primary polydipsia has proven very difficult and complex stimulation testing is needed for the diagnosis of AVP-D and primary polydipsia. This study will look at the response of the body's pituitary gland to a single dose of a medication called tolvaptan compared to placebo to see if this could be used as a new and simpler test for the diagnosis of these conditions.

Following a tooth extraction, the body responds and adapts the bone around the extraction site in its normal healing process. Inevitably, this results in a decrease in the amount of bone and gum tissue at the extraction site. Dental implants are reliant on bone to facilitate their placement and support the implant as it functions as a tooth replacement. As such, minimising bone loss after an extraction is key to optimise the success of implant placement. Bone grafting techniques are commonly used to assist the body in healing promoting the maximum preservation of bone. New materials are available which aim to stimulate the body’s healing ability when used in conjunction with a standard grafting material. This study aims to evaluate the effectiveness of using a biological stimulating product (a viscoelastic gel containing hyaluronic acid and polynucleotides) in conjunction with the grafting material to maximise the healing response after an extraction.

The use of constraint-induced movement therapy in the upper limb is now a renowned ‘green light’ therapy for the treatment of children living with cerebral palsy where one side of their body is affected (unilateral cerebral palsy - UCP). This involves constraining the non-affected upper limb with a mitt or a splint in order to encourage targeted use of the affected limb to improve function. Currently, however, there are no well researched interventions targeted at the lower limb of infants and toddlers living with cerebral palsy, despite the knowledge that independence in gross motor skill acquisition positively affects cognitive development and the timing of critical window of motor neuronal development. We wish to investigate the feasibility and acceptability of this intervention on infants and toddlers, 10-18 months of age living with unilateral cerebral palsy. The key objectives of this research study include: 1. Is Baby Lower Extremity Constraint Induced Movement Therapy (Baby LE-CIMT) feasible for carers and therapists and acceptable to referrers of infants and toddlers with unilateral cerebral palsy? 2. What is the effect of Baby LE-CIMT on gross motor function, cognitive function, muscle volume and gait parameters in infants and toddlers with UCP?

Complications after major surgery are common and decrease survival in the short and long-term. Tissue hypoxia (low oxygen) is established as a driver of postoperative complications. All complex cells can adapt to low oxygen conditions, over a period of hours to days, by activating the highly conserved hypoxia inducible factor (HIF) pathway. Roxadustat is a first-in-class oral prolyl hydroxylase inhibitor that increases HIF signalling and is currently marketed for the treatment of anaemia in chronic kidney disease. Brief preoperative Roxadustat exposure stands to prime cells to function well under the anticipated hypoxic stress of major surgery, a clinical insult that is unique due to its precise timing. In particular, Roxadustat may enhance immune cell function and healing in the hypoxic microenvironment of the surgical wound, thereby reducing the burden of surgical site infection. Hypothesis: A definitive phase 3 randomised controlled trial of preoperative roxadustat vs placebo in patients undergoing major noncardiac surgery is safe, feasible and justified.

Why this study is important? Healthcare-associated infections (HAIs) are acquired as a direct or indirect result of healthcare. Infections associated with healthcare are not inevitable, and prevention programmes have been successful at reducing the incidence of some HAIs. In Australia, we have estimated 160,000 patients contract a HAI annually. Furthermore, one in ten patients today have an infection acquired in hospital. Non-ventilator hospital-associated pneumonia (HAP) is the most common type of HAI, accounting for approximately one third of these infections, with an estimated 50,000 patients affected each year in Australian public hospitals alone. HAP is associated with increased length of stay in hospital, increased morbidity, mortality, and healthcare costs.Approximately 19% of patients with HAP require transfer into an intensive care unit (ICU), with mortality reported at 18%. Patients with HAP are eight times more likely Our study will: Evaluate the effectiveness and cost-effectiveness of the intervention Develop educational and digital resources and evaluate these as part of the trial Estimate excess length of stay in hospital associated with HAP Describe the patient’s experience of a having a HAP Understand the clinician’s experience of implementing the intervention Assess the impact of HAP on quality of life

This RCT experimental design with mixed methods aims to investigate a play-based intervention before, during and after a vaccination procedure. Play based modalities may be useful to prepare children for vaccinations to reduce fear responses and improve coping through age-appropriate health education initiatives. Parents will also be invited to assess their child’s coping before and after the vaccination. Play assessments will be utilised to assess children’s play ability and coping resources. These assessments will then inform the pre-vaccination play therapy intervention. This research is the first of its kind that uses eye tracking technology and play therapy methods.

little is known about the gastrointestinal effects of these sweeteners, particularly in people with irritable bowel syndrome (IBS). This study will compare for the first time, the tolerability of 5 sweeteners - erythritol, monk fruit extract, stevia, allulose and sucrose in people with IBS whose symptoms are well controlled on a low FODMAP diet. The low FODMAP diet restricts intake of six sugars - fructose, lactose, oligosaccharides (fructans and galactooligosaccharides), and sugar polyols (sorbitol, mannitol). These six sugars are well known to trigger symptoms in people with IBS, and their collective reduction via a low FODMAP diet relieves symptoms in around 3/4 people with the condition.

This study aims to evaluate if the use of the T-stat oximeter device for breast cancer patients undergoing DIEP flap reconstruction procedures can improve post-operative sleep quality. Patients above the age of 18 year old who are diagnosed and treated for breast cancer and are about to undergo a DIEP flap reconstruction procedure are eligible for this study after appropriate consent is obtained. Participants will be randomised into either the control group or interventional group and are required to complete surveys at different timepoints of the study that evaluates sleep quality and quality of life. Control group patient will be monitored with current gold standard of care via observational and sonography ultrasounds while intervention group patients will under monitoring via the T-stat device. Results of this study aims to better future care for breast cancer patients and reduce post-operative sleep disturbance related complications.